Senior QA Auditor, GMP - Hybrid

Merck; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck in Rahway, NJ seeks a Senior Specialist, Quality Assurance who reviews and approves GMP documentation for clinical supply drug product, audits batch documentation, and supports regulatory inspections.

You will collaborate with the Quality Program Lead to issue reports, drive corrective actions, and ensure adherence to GMP. On-site support for production occurs at least 60% weekly.

Qualifications

• Bachelor's degree in a science or engineering field is required.
• Minimum of 5 years' experience in the pharmaceutical industry.
• Strong knowledge of GMP, GDP and EU regulatory requirements.
• Experience in QA, QC, analytics, or manufacturing environments.

Responsibilities

• Review and approve GMP documentation for internal or outsourced clinical supplies.
• Audit batch documentation, data, procedures, and systems for compliance.
• Collaborate to issue audit reports and resolve findings with management.
• Participate in regulatory inspections preparations and execution.
• Ensure release criteria are met and maintain GMP standards.
• Lead investigations using root cause analysis and CAPA.
• Provide on-site support to production facilities (60% weekly).

Skills

Continuous Improvement

Good Documentation Practices

Good Manufacturing Practices

Quality Assurance

Standard Operating Procedure

Education

B.S. in appropriate Science or Engineering discipline

Job description

Merck in Rahway, NJ seeks a Senior Specialist, Quality Assurance who reviews and approves GMP documentation for clinical supply drug product, audits batch documentation, and supports regulatory inspections.

You will collaborate with the Quality Program Lead to issue reports, drive corrective actions, and ensure adherence to GMP. On-site support for production occurs at least 60% weekly.